Study suggests follow-on biologics legislation may wait a year

WASHINGTON Follow-on biologics might have to wait another year for legislation to be introduced after there was hope it would be introduced this year after it was unable to slip into legislation before the end of last year, according to The Regulation Policy Market Access Report.

Some of the reasons for the delay are: Sen. Ted Kennedy’s, D-Mass. health, the presidential election, and the Medicare bill. Even before Kennedy became sick with a malignant brain tumor, the chairman of the Senate Health, Education, Labor & Pensions Committee had said that it would be difficult to get legislation to move because of the high number of other high-profile legislative priorities ahead. The Medicare compromise looks to be the only major health legislation that will make it through Congress in 2008 and if that is the case, follow-on biologics would have to add itself to that bill. Finally with the election, Congressional leaders will be out supporting their respective candidates for the rest of 2008 and then the first half of 2009 will be spent on setting up the new administration.

One factor that seems positive for follow-on biologics is, a report from the Pharmaceutical Care Management Association estimated that cost-savings from follow-on biologics for the top 200 Medicare Part B- reimbursed therapies would be about $14 billion over 10 years. As a result of this, the Congressional Budget Office is conducting a study of its own to see the 10-year savings with follow-on biologics. If the numbers match, it would be difficult for Congress to pass up looking up at relatively soon.

Researchers develop online tool for tracking children’s immunizations

ATLANTA Researchers at the Georgia Institute of Technology have developed an online tool to help parents and pediatricians adjust childhood immunization schedules when one or more vaccinations are missed.

When a child falls behind in the vaccination schedule, doctors must determine when it’s appropriate to give any missed vaccines or future vaccines. This usually requires the creation of a personalized catch-up schedule for each child, something that’s often done while the child sits in the treatment room. The online tool is designed to ensure that missed and future vaccines are given without violating guidelines regarding vaccines and doses.

“Physicians have been telling us for years that they needed a computerized program to tell them when to give vaccines after a child misses scheduled immunizations. Now this tool is available for health care professionals and parents to use, and they are excited to use it,” said Larry Pickering, executive director of the CDC’s Advisory Committee on Immunization Practices and a collaborator on the project.

When using the tool, a doctor or parent inputs a child’s date of birth and previous immunization dates. The program then creates a personalized schedule of the recommended dates to administer all future vaccines. It offers two options—administer the vaccines as soon as possible or administer the vaccines when recommended.

HHS awards contracts for speedy flu identification test

WASHINGTON If the world ever faced an avian influenza pandemic, how would doctors distinguish it from the seasonal flu?

Health and human services department secretary Mike Leavitt announced Thursday that the Centers for Disease Control and Prevention had awarded $12.9 million in contracts to two pharmaceutical firms for the development of tests that could distinguish the common flu from the lethal H5N1 form within three hours.

The two companies are San Diego-based Nanogen, and Gaithersburg, Md.-based Meso Scale Diagnostics, each of which received about $6.5 million for the contracts. The contracts provide funding of up to $10.4 million for Nanogen and $12.1 million for Meso Scale Diagnostics for further developments up to three years.

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The workshops, sponsored by McKesson, have been offered by the Alexandria, Va.-based organization for more than 20 years and are slated to take place June 8-10 in Denver, Colo., and Oct. 4-6 in Boston.

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